Baltimore Plant Where J&J Doses Were Ruined Ordered to Temporarily Stop Production
Federal regulators authored a 12 page report citing several examples of misconduct within the plant, including improperly trained employees.
On Wednesday, federal regulators ordered the Baltimore plant, operated by Emergent BioSolutions, where nearly 15 millions doses of the Johnson & Johnson vaccine were ruined to temporarily stop all of its production.
The US Food and Drug Administration (FDA) issued some highly critical findings and cited a series of shortcomings at the plant in their decision.
The inspection was initiated after reports had come to the surface that workers at the plant had accidently contaminated J&J doses with the virus from the AstraZeneca vaccine, which is also manufactured at there.
The FDA included 9 violations in their 12 page report, including a failure to properly disinfect the factory and its equipment, a failure to follow proper procedures which are designed to prevent contamination of doses and having improperly trained employees.
For example, the investigators had discovered that employees would often move back and forth between working with the J&J vaccine and the AstraZeneca doses, without documenting that they had taken the necessary precautions to ensure integrity and cleanliness.
The FDA finished their inspection of the pant on Tuesday.
Noted in the report is that the FDA has not authorized the plant to distribute any does of the vaccines, and that none from the pant have thus far been released for use in the country.
“We will not allow the release of any product until we feel confident that it meets our expectations for quality,” Janet Woodcock, the FDA’s acting commissioner said.
Changes have already begun at the plant, including that they will no longer be manufacturing the AstraZeneca vaccines, as was insisted on by federal officials to limit the potential for cross-contamination.